6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA

NCT00360243 | Completed Phase 3 Results DMC

• 1 other identifier: 511.70
• Study Type: interventional
• Target: 1,385
• Locations: 1 country
• Sites: 81

Brief Summary

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Conditions

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.

  A small personal handheld electronic device (eDiary) was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.

  24 weeks

• Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.

  Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read "Indicate your most intense level of sexual desire in the last 24 hours / since your last visit." Potential responses included "no," "low," "moderate," or "strong" and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire: 0 = No desire 1. = Low desire 2. = Moderate desire 3. = Strong desire

  baseline to 24 weeks

Study Arms (4)

flibanserin 25 mg b.i.d

EXPERIMENTAL

25 mg twice daily for 24 weeks

Drug: flibanserin

flibanserin 50mg qhs

EXPERIMENTAL

50 mg taken once daily at bedtime for 24 weeks

Drug: flibanserin

flibanserin 50mg b.i.d.

EXPERIMENTAL

50 mg twice daily for 24 weeks

Drug: flibanserin

placebo

PLACEBO COMPARATOR

twice daily for 24 weeks

Drug: placebo

Interventions

flibanserin DRUG

Experimental: flibanserin 25 mg b.i.d

flibanserin 25 mg b.i.d

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women who are 18 years of age and older.
• Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
• Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
• Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
• Patients must be willing and able to use an electronic diary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
• At the Baseline Visit, patients must have complied with eDiary use adequately.
• Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
• Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
• In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
• Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
• Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.

You may not qualify if:

• Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
• Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
• Patients with a history of drug dependence or abuse within the past one year.
• Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
• Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
• Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
• Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
• Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
• Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
• Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
• Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.

Sponsors & Collaborators

• Sprout Pharmaceuticals, Inc: lead

Study Sites (81)

511.70.01068 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

511.70.01040 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

511.70.01041 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

511.70.01003 Boehringer Ingelheim Investigational Site

Jonesboro, Arkansas, United States

Location

511.70.01070 Boehringer Ingelheim Investigational Site

Carmichael, California, United States

Location

511.70.01026 Boehringer Ingelheim Investigational Site

Redding, California, United States

Location

511.70.01015 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.70.01014 Boehringer Ingelheim Investigational Site

Stanford, California, United States

Location

511.70.01017 Boehringer Ingelheim Investigational Site

Tarzana, California, United States

Location

511.70.01072 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Location

511.70.01078 Boehringer Ingelheim Investigational Site

Vista, California, United States

Location

511.70.01066 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

Location

511.70.01064 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

511.70.01001 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

511.70.01050 Boehringer Ingelheim Investigational Site

Farmington, Connecticut, United States

Location

511.70.01006 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Location

511.70.01055 Boehringer Ingelheim Investigational Site

New London, Connecticut, United States

Location

511.70.01024 Boehringer Ingelheim Investigational Site

Aventura, Florida, United States

Location

511.70.01056 Boehringer Ingelheim Investigational Site

Daytona Beach, Florida, United States

Location

511.70.01090 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

511.70.01027 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

Location

511.70.01062 Boehringer Ingelheim Investigational Site

New Port Richey, Florida, United States

Location

511.70.01043 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

511.70.01084 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

511.70.01048 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

511.70.01042 Boehringer Ingelheim Investigational Site

Stuart, Florida, United States

Location

511.70.01063 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

511.70.01085 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

511.70.01086 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Location

511.70.01022 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

511.70.01057 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

511.70.01087 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

511.70.01052 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Location

511.70.01060 Boehringer Ingelheim Investigational Site

Champaign, Illinois, United States

Location

511.70.01058 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

511.70.01032 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

511.70.01018 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

511.70.01007 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Location

511.70.01047 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

511.70.01079 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

511.70.01031 Boehringer Ingelheim Investigational Site

Saint Louis, Maryland, United States

Location

511.70.01011 Boehringer Ingelheim Investigational Site

Haverhill, Massachusetts, United States

Location

511.70.01028 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

511.70.01081 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

511.70.01082 Boehringer Ingelheim Investigational Site

Billings, Montana, United States

Location

511.70.01077 Boehringer Ingelheim Investigational Site

Moorestown, New Jersey, United States

Location

511.70.01019 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

Location

511.70.01076 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

511.70.01025 Boehringer Ingelheim Investigational Site

Poughkeepsie, New York, United States

Location

511.70.01067 Boehringer Ingelheim Investigational Site

Purchase, New York, United States

Location

511.70.01016 Boehringer Ingelheim Investigational Site

Mount Airy, North Carolina, United States

Location

511.70.01044 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

511.70.01049 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

511.70.01089 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

511.70.01054 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

511.70.01075 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

511.70.01002 Boehringer Ingelheim Investigational Site

Mayfield Heights, Ohio, United States

Location

511.70.01065 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

511.70.01083 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

511.70.01036 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

511.70.01004 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

511.70.01021 Boehringer Ingelheim Investigational Site

West Reading, Pennsylvania, United States

Location

511.70.01073 Boehringer Ingelheim Investigational Site

Warwick, Rhode Island, United States

Location

511.70.01023 Boehringer Ingelheim Investigational Site

Anderson, South Carolina, United States

Location

511.70.01035 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

511.70.01008 Boehringer Ingelheim Investigational Site

Nasville, Tennessee, United States

Location

511.70.01020 Boehringer Ingelheim Investigational Site

Corpus Christi, Texas, United States

Location

511.70.01009 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

511.70.01030 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

511.70.01091 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

511.70.01013 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

511.70.01005 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

511.70.01061 Boehringer Ingelheim Investigational Site

Sandy City, Utah, United States

Location

511.70.01010 Boehringer Ingelheim Investigational Site

Burlington, Vermont, United States

Location

511.70.01012 Boehringer Ingelheim Investigational Site

Charlottesville, Virginia, United States

Location

511.70.01046 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

511.70.01029 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

511.70.01071 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

511.70.01033 Boehringer Ingelheim Investigational Site

Bellevue, Washington, United States

Location

511.70.01039 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

511.70.01069 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

flibanserin

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Krista Barbour, Ph.D.
• Organization: Sprout Pharmaceuticals

kbarbour@sproutpharma.com

9198820850

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 4, 2006
• Study Start: July 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 27, 2016
• Results First Posted: June 27, 2016

Record last verified: 2016-06

Locations

US (81)